(MONEY Magazine) – Nearly a decade after the U.S. began testing donor blood for AIDS, people continue to contract the disease through transfusions. The reasons for this deplorable state of affairs range from human error to flawed medical tests, from legal loopholes to plain old double-talk that obscures this fatal fact: Concerns about costs often outweigh those about human life. For example, antigen testing, a procedure that can help eliminate a main cause of contamination, has not been judged cost-effective enough by the U.S. Food and Drug Administration to be made mandatory. The test, which could have saved Catalina Grigley (shown at left) from AIDS, would increase by approximately $3 the $50-to-$120 price for a unit of blood that can service three patients. How many Americans has donor blood infected with HIV, the virus that causes AIDS? What are the odds of acquiring AIDS from transfusions today? The answer to both questions is that, because of bureaucratic laxity in the $1.75 billion blood industry, no one knows for sure. But perhaps a more critical question is: Have American Red Cross and other blood banking leaders and their regulators at the FDA done all that they can do to reduce the odds of acquiring HIV through blood products? A comprehensive investigation by MONEY concludes that the answer is no. Says Ross D. Eckert, who from 1987 through 1993 was the first voting representative of consumer interests on the FDA's Blood Products Advisory Committee: "The process through which the FDA gets information to make important safety decisions is heavily skewed in favor of the blood banking industry over consumers." Consider, for example, the lack of progress in one main area of concern, human error at blood-donor facilities run by the Red Cross and other organizations. The problems had become so severe that a year ago the FDA filed suit in U.S. District Court to force the Red Cross to correct safety violations at centers across the country. This month the FDA is scheduled to review reports of recent inspections of the centers. Copies of earlier reports that have been obtained by Money show, among other violations: -- At the Huntington, W.Va. Red Cross center between July 1985 and November 1991, 46 people were allowed to donate blood after testing positive on HIV screening tests. -- At the Wadley Blood Bank in Dallas beginning in August 1990, at least two regular donors tested positive repeatedly for HIV-2, another less common strain of the AIDS virus, yet were not barred from giving blood until December 1991. -- In San Francisco, a July 1992 inspection of Irwin Memorial Blood Centers concluded that "it cannot be determined from existing records that viral marker testing (for HIV and hepatitis) was performed according to test kit and equipment instructions." Moreover, blood was accepted from people who had tested positive for HIV and hepatitis, and distributed for transfusion. -- In Portland, Ore. an August 1993 inspection of the Red Cross center revealed that 46% of the lab staff performing HIV testing "were not aware" of -- a critical test step." A March 1992 inspection of the same facility had uncovered an inadequate review of testing results, leading to the release of incompletely tested or untested blood products.

More than 6,050 people diagnosed with AIDS from transfusions have been reported to the Centers for Disease Control, with 29 of them infected after HIV testing began in 1985. But CDC and blood bank officials acknowledge that those figures don't re ect the true extent of HIV transmission, primarily because they include only people who have been infected long enough to develop symptoms that meet the CDC's definition of AIDS, a process that on average takes 10 years. Jack Showers, a Lafayette, La. attorney, offers some perspective on how much of an understatement the CDC figures may be. "I remember just laughing several months back when the CDC was reporting that there were a total 18 cases of AIDS resulting from transfusions since testing began. At that time, I had three clients who had been infected through transfusions after 1985, and I'm just one small-time lawyer in rural Louisiana, so you tell me how I could end up with one-sixth of all the cases in the country." Estimates on the risk involved in transfusion vary greatly because researchers use different methods for discerning the odds of getting AIDS through blood. The American Red Cross, which collects half of the nation's blood supply, and the American Association of Blood Banks, the industry trade association whose members include the hospital and community blood banks that collect the remainder, both cite the same estimate: 1 in 225,000. That figure is the risk per screened unit, meaning that 1 out of every 225,000 units of blood that have been tested may nonetheless carry HIV. But patients rarely receive a single unit of blood -- the average is 5.4 units per transfusion -- and risk rises with the number of units a patient receives. When adjusted to re ect the average odds per transfusion, the figure the blood bankers cite is 1 in 41,666. That estimate comes from a 1990 study conducted by CDC in collaboration with the Red Cross and is based on mathematical projections. But other researchers have come up with estimates by actually testing people for HIV after they have received blood. John Ward, the CDC's head of AIDS surveillance, regards this as the "best way to find out the real risk." One such study published in the October 1992 Annals of Internal Medicine showed that the resulting odds were significantly higher. The conclusion was based on post-transfusion testing of 11,532 patients in Houston and Baltimore hospitals who had received 120,312 units of blood during surgery between 1985 and 1991. Two had been infected, which translated into odds of 1 in 11,111 per transfusion. Whether the average risk per transfusion is 1 in 41,000 or 1 in 11,000, it is obviously a dramatic improvement over the 1 in 487 odds that prevailed before HIV testing began in 1985. Also, as blood bankers are quick to point out, current HIV transfusion risk compares favorably to other common medical dangers: The chance of dying from in uenza, for instance, is 1 in 10,000, according to Joe Bressee of the CDC. That means you should be cautious and follow the advice in the box on page 139 when you need blood but should not reject an immediate transfusion in a life-threatening emergency. And when considering the risks of transfusion, note that hepatitis is a greater threat than AIDS -- the odds are 1 in 3,000. But AIDS is uniformly fatal, and mass statistics provide little comfort in the face of such devastatingly singular human consequences.

A 35-year-old Ridgewood, N.J. woman who asks to be identified as Jane Doe underwent hip surgery in September 1986, looking forward to a new life free from the chronic joint pain she'd suffered for years. When her doctor called the following summer to ask her to stop by as soon as possible, she assumed he was responding to her application for a job in his office. "She was white as a ghost when she came home," recalls her husband. "After our kids -- who were nine and seven then -- were in bed, she told me that the doctor wanted her to be tested for AIDS because the donor of blood she'd received during the operation had come back to donate and this time tested positive. My wife was tested, we found out she was infected by blood that was supposed to be safe, and life has been hell ever since." Jane has not developed AIDS symptoms yet, but the emotional trauma is inescapable. "This disease is constantly on my mind," she says. Like most Americans, Jane Doe relied on blood bankers and FDA regulators to establish procedures that would protect transfusion recipients. But a nationwide investigation by Money in the 1980s, reported in the ground- breaking March 1986 article "Inside the Billion-Dollar Business of Blood," concluded that decisions about blood safety were not always made wisely. In the wake of renewed public concern about transfusions following word last fall of AIDS-tainted blood in Germany, Money again launched reporting across the country to assess the safety of the U.S. blood supply. Our judgment: America can still do better. The ways in which crucial decisions are made remain biased toward the blood banking industry's business interests. Moreover, blood bankers have successfully lobbied for passage of laws in most states that give them unique protection from strict liability. Unlike other businesses, blood banks can't be held liable for injury resulting from their product unless negligence can be proved. And in most cases, a blood bank can't be found negligent as long as it can show that its actions conformed to "due standard of care," which is usually defined as whatever was customary in the blood industry. Blood bankers carefully coordinate any actions, following agreed-upon guidelines. Since the FDA relies heavily on them for advice on any rules it lays down, the end result is that the industry pretty much sets its own standards. This system has enabled HIV to continue to spread by transfusion. An examination of the three main causes of contamination today points up the difficulties of creating change in an entrenched community of interests.

AN OPEN WINDOW LIKE MOST U.S. BLOOD BANKERS, Oklahoma Blood Institute president Ronald O. Gilcher was aware two years after the start of HIV-antibody testing that some people were still being infected by transfusion. And like most in the industry, he speculated that the infections resulted from HIV-positive donations from people who were in the window period -- the time it takes a newly infected person to develop the antibodies that screening tests are designed to detect. That window period is estimated to range from a few weeks to six months. ! "Closing the window is especially important now, given the sharp rise we're seeing in heterosexual transmission of HIV," says Gilcher. "Young heterosexual people are our blood donors. Donor questioning about high-risk activity won't screen them out." Gilcher reported his first window case in September 1990, when a regular donor who had tested HIV-negative two months earlier returned and tested positive. Gilcher retrieved the frozen sample of the man's donation that had passed the earlier screening test and found it still showed up negative on all six antibody screening tests licensed for use by blood banks at that time. However, the infected unit was caught by one new type of test called an antigen test, which identifies a substance that appears in blood sooner than antibodies do -- usually within two or three days after the HIV virus has invaded the body. The FDA in 1989 had recommended against using the antigen test to screen blood donors, citing studies that showed it was not effective. However, Gilcher not only used the antigen test to find blood that registered HIV positive but in tracing the unit of blood to a recipient learned it had passed on the AIDS virus. The victim was Catalina Grigley, a 47-year-old woman who had undergone elective heart surgery near her home in Corona, Calif. in August 1989. A year later, research revealed that use of the antigen test would have prevented another donor's blood from infecting a Houston patient with HIV. The debate in deciding whether to add any new test inevitably centers on whether the benefits justify its costs. The FDA estimates that implementing the antigen test at a cost of about $3 per unit would add $50 million to $70 million annually to the nation's $942 billion health-care bill. How many cases, then, must you demonstrate that you can prevent with antigen testing to justify those added costs? Two, 10, 100? When asked that question, blood bankers and FDA officials alike say that they have no answer. But Catalina Grigley says: "If I had known there was a test that could have prevented me from getting AIDS from my transfusion, even if the odds of getting it were low, I would gladly have paid $100 for that test. But nobody gave me the choice."

A FAVORED SUPPLIER WITH MUCH FANFARE IN MARCH 1985, U.S. Secretary of Health and Human Services Margaret Heckler announced that the first AIDS screening test license had been granted to Abbott Laboratories. Licenses for four other manufacturers followed quickly, so that by the fall of 1985 there were five tests on the market. At a meeting of the U.S. Public Health Service that took place on May 14, 1986, Alfred Saah, a National Institutes of Health researcher at Johns Hopkins University, told FDA and blood bank officials that in evaluating test kits from all manufacturers, he'd found that Abbott's test correctly identified only 13 out of 30 blood samples known to be HIV-positive. Test kits from two other manufacturers, Genetic Systems and Du Pont, detected 25 of the samples, or 83%, vs. only 43% for Abbott's test. Saah's alarming data confirmed a problem that Red Cross, FDA and Abbott officials had already discussed in internal correspondence that Money has obtained. The Red Cross nevertheless chose Abbott to supply 85% of its test kits for the 12-month period beginning July 1, 1986, with Genetic Systems providing only 15%. A week into the new contract, however, incontrovertible evidence of the Abbott test's inferior ability to detect HIV-positive blood was presented at another meeting of the U.S. Public Health Service. Red Cross vice president of medical operations Gerald Sandler publicly stated that his organization's blood banks soon would be supplementing the Abbott test with two other tests -- a promise that was not fulfilled. Minutes of a mid-November meeting of blood center directors reveal a Red Cross official saying no blood center was likely to be held negligent for using an FDA-approved procedure even if other tests were claimed to be more sensitive in detecting HIV-positive donors. Notably absent in the discussion of legal consequences was any expression of concern by Red Cross officials for the transfusion recipients. A 17-year-old boy in Chicago acquired the AIDS virus through United Blood Services blood that tested falsely negative on the Abbott test in September 1985. He is one of at least three transfusion recipients who have filed lawsuits not just against blood banks but also against Abbott, charging that the manufacturer should have informed technicians performing the test about its potential for false negatives. Among the plaintiffs is Jane Doe of Ridgewood, N.J., who was infected by a unit of blood that tested falsely negative on the Abbott test four months after blood bank industry leaders and the FDA saw data showing the test missed more than half of HIV-positive blood samples. Abbott's official response to the lawsuits contends that the standard package insert, citing that a negative result doesn't preclude the possibility of HIV infection, was sufficient warning and notes that Abbott tests "have met all the FDA's licensing requirements." One of the lawsuits that is now pending against Abbott raises questions about whether even an improved version of the test released in January 1987 continued to register more false negatives than other manufacturers' tests. A 73-year-old woman from rural Kansas who was undergoing heart surgery was infected with HIV from blood that tested negative on the Abbott test in April 1987. On retesting, the blood bank found that the unit that infected the woman, who died of AIDS in 1992, was consistently positive on Du Pont's test, positive two out of three times on Genetic Systems' and consistently negative on Abbott's. Abbott revamped its test yet again in 1991 to improve its sensitivity and to detect HIV-2. The company remains the exclusive supplier of AIDS screening tests for the Red Cross and has more than half of the HIV screening test market overall.

THE HUMAN FACTOR ALTHOUGH MOST BLOOD BANKERS CLAIM THAT transmission today results from window period donors, Edgar Engleman, director of the Stanford Medical School Blood Center, disagrees. He contends that blood bank laboratory and clerical errors account for at least half-if not more -- cases of HIV infection through transfusion. The first documented case of HIV transmission caused by human error in a blood bank was reported in October 1992 at the Greater New York Blood Bank, which discovered that a unit of blood used for the transfusion had tested positive for HIV but had been released anyway. Since then, as the FDA inspection reports cited earlier show, an abundance of human errors has been uncovered. The stepped-up FDA scrutiny is part of a tough new policy to impose stricter regulations on blood bank employees, initiated under pressure from congressional investigations of lax industry safety standards. A revolving door between the FDA and blood bank management has always turned briskly, with today's blood banking executive becoming tomorrow's friendly FDA regulator and vice versa. But as evidence of changing times, the FDA filed its lawsuit against the American Red Cross in May 1993, and the Red Cross is now operating under the terms of a court-enforceable consent decree with the FDA, which requires it to take action to reduce errors and streamline operations. As a result, the Red Cross is consolidating testing in 10 new centrally controlled laboratories rather than at its 47 regional blood-collection centers. In addition to lab and clerical error, questionable judgment on the part of blood bank management has also led to unnecessary HIV infection. In Los Angeles, the Red Cross has often waited as many as seven years before notifying transfusion recipients that they were likely to have been infected with HIV. Failure to provide timely notification not only robs recipients of the chance to get life-prolonging treatment but can result in their unwittingly spreading the virus to others, as happened to Ora Swain of Lapoint, Utah. In January 1985, Ora's husband Orville acquired AIDS from a blood transfusion at age 76 during heart bypass surgery. Though blood bank officials in Salt Lake City learned five months following the surgery that one of their blood donors was HIV-positive, they did not trace the recipients of the transfusions. Swain was among them. Since he and his wife did not resume sexual relations until a year after the surgery, prompt notification by the blood bank could have saved Ora's life. Instead, she became sexually infected and died of AIDS in 1987, a year before the disease also took her husband's life. Their daughter, Joleen Swain Ottosen of Woodland Park, Colo., has become a crusader for blood safety and has written a book about it (see the box on page 139). Joleen's concern has been enlarged by the plight of a third member of the family, her cousin's son, Jonathan Swain of Jefferson, Iowa, who was infected by HIV-tainted blood during a transfusion he received to help cure a strep infection two days after birth in 1983. Now 11, Jonathan is among the longest-surviving children with AIDS in the U.S. Poor management decisions have been evident at all levels of the blood industry. For instance, when HIV antibody tests became available in March 1985, no specific rules were issued by the FDA or blood bank organizations about how or when testing should be implemented. As a result, many blood banks began using the tests to screen new blood donations but did not bother to test blood in inventory. The fact that blood bankers would fail to take a step that was so obviously in the best interest of transfusion recipients is some measure of what happens when the industry is left to its own devices. Based on interviews with more than 75 blood industry insiders, experts and critics, Money has concluded that the following moves would provide an important first step toward reordering the blood business' priorities: -- Reduce blood industry in uence over the FDA's Blood Products Advisory Committee. This committee advises the FDA on crucial public policy issues, such as deciding whether to implement new screening tests, and the FDA nearly always follows the recommendations. A blood banker traditionally has chaired the 11-member committee, and blood bankers or those with an industry bias make up more than a third of its current membership. -- Make greater efforts to eliminate contaminated blood from window- period donors. The antigen test should be used until superior techologies are available for use on a mass scale. -- Rely as much as possible on groups of low-risk repeat donors rather than random blood donors. -- Subject blood banks to stricter liability for their products. Even if the risk of transfusion-transmitted HIV is eliminated, the way in which blood bank organizations and the FDA have responded to this problem must be scrutinized. In an era of global travel, blood-borne viruses and parasites appearing in a remote corner of the world can quickly migrate to highly populated areas. "How the blood bank industry has responded to HIV is important, because it's just one of many dangers in blood, and new ones continue to emerge," says Edgar Engleman of the Stanford Medical School Blood Center. "One would hope that some important lessons have been learned in this industry. Only time -- and the appearance of the next blood-borne virus -- will tell."

BOX:

Stricter safety standards could have saved this woman from AIDS. A new MONEY investigation reveals continuing flaws in the system.

Lax blood procedures caused his aunt and uncle to die of AIDS. Infected with HIV from a transfusion, Jonathan Swain survives.

To eliminate risks, use your own blood for a transfusion.